Wednesday, February 29, 2012

In 1998, the Attorneys General of 46 states praised themselves for having negotiated a litigation settlement with Big Tobacco that they said had brought to tobacco companies to their knees. At the time of the settlement, Florida's Attorney General - Bob Butterworth - proclaimed that "'The Marlboro Man will be riding into the sunset on Joe Camel."

Even today, the National Association of Attorneys General boasts that: "The MSA is a historic, landmark agreement that affects the lives of all Americans. It generates billions of dollars for Settling States to cover the health care costs generated by smoking and has played a significant role in bringing about a decrease in smoking rates among adults and youth in the United States."

I have long argued that the Master Settlement Agreement was a public health disaster, a huge blunder by the Attorneys General who negotiated and agreed to it. I agree that it is a landmark agreement that affects the lives of all Americans, but not in a good way. It made the states fiscal partners with the tobacco companies, destroying the incentive for states to take any actions that would significantly decrease tobacco sales and revenues. Most of the money that was supposed to be spent on tobacco education, prevention, and treatment has been diverted to all sorts of other uses, mainly to plug holes in state budgets. And in return, what did the tobacco companies get? They were let off the hook in litigation in 46 states, in return for a significant but fiscally stable and predictable payoff. It was a brilliant move by the tobacco companies and a stupid, politically-motivated move by the Attorneys General.

The Rest of the Story

Last week came word that due to the Master Settlement Agreement, California is facing major fiscal problems. You see, it seems that cigarette smoking has been decreasing more rapidly than expected and this decline in cigarette consumption is affecting payments to the state under the MSA. Since the state decided to borrow money against its expected future payments, the declining revenues affect its ability to pay back investors in bonds that were used to securitize the future payments. According to an article in California Watch, there are currently $2.9 billion in outstanding bonds. The need to pay back investors in these bonds could create fiscal havoc, aggravating an already terrible budget situation.

According to the article: "Fewer smokers is bad news for California’s budget. A major bond rating agency sounded an alarm this month, saying the state may have borrowed more than $4 billion against settlement money that might never materialize. A little more than a decade ago, 46 state attorneys general reached a settlement with the four biggest tobacco companies. The companies agreed to pay an estimated $246 billion over a 25-year period to compensate states for tobacco-related health care costs. But there is one quirk: The settlement payments are not fixed, but linked to tobacco sales. Rather than waiting for annual payments, the state and some local governments decided to borrow money against their anticipated future revenue. All told, they’ve issued $16 billion in bonds since 2001. Major bond rating agencies and some municipal finance experts have warned for years that the number of smokers was decreasing more rapidly than expected."

"In December, California had to dip into its reserves to cover bond payments. Dick Larkin, director of credit analysis at Herbert J. Sims & Co., said there were two reasons: fewer smokers and a dispute with the tobacco companies that has resulted in delayed payments.As the state’s finances worsened, officials went back to investors. In 2007, California issued $4.4 billion in tobacco bonds. In order to pay back investors by 2047, it assumes that cigarette consumption will decline by about 1.8 percent per year, according to bond filings. But in the midst of increased taxes and antismoking laws, sales have dropped more quickly than predicted. As a result of the decline and the ongoing dispute with the tobacco companies, annual payments have been less than expected since the settlement was signed in 1998, according to Larkin. If the bonds default, it wouldn’t be bad just for investors. California is one of only a few states that guaranteed a portion of its bonds with general fund revenue. If tobacco settlement money does not cover the debt, the state will have to pick up some of the tab. There are currently $2.9 billion in bonds outstanding that are backed by a state guarantee, according to the state treasurer's office. Although that payment would be subject to legislative approval, it’s unlikely it wouldn’t be approved. “No one would trust California anymore,” Larkin said. “Their name would be mud in the market.”"

This story illustrates the brilliance of the Master Settlement Agreement (from the perspective of the cigarette companies). The states are now fiscally dependent on a steady stream of cigarette revenues. Any substantial drop in cigarette smoking threatens the state's fiscal situation. Thus, there is no incentive to take any action that will substantially reduce cigarette sales. Perhaps this is why we haven't seen many major anti-tobacco initiatives at the state level since the Master Settlement Agreement was signed. We've seen mostly minor initiatives that dilly dally around the margins, but very few which actually aim to put a major dent in cigarette sales.

In direct contrast to what the Attorneys General predicted, the Marlboro Man isn't riding into the sunset on Joe Camel. Instead, they're both having a beer and a good laugh together as they enjoy their trip to the bank.

Tuesday, February 28, 2012

In a statement issued late last week, the Campaign for Tobacco-Free Kids decried the involvement of the tobacco industry in trade policy negotiations. The U.S. is in the process of negotiating the Trans-Pacific Partnership (TPP) Agreement with eight other countries. The Campaign for Tobacco-Free Kids believes that this agreement could have implications for tobacco policy.

According to the Campaign's statement:

"As the United States and other countries negotiate a trade agreement that could impact efforts to reduce tobacco use worldwide, Philip Morris International is trying to buy access and influence by sponsoring an exclusive corporate reception Friday in Washington, DC, that will be attended by top trade and other officials from the countries involved. We urge government officials not to attend this tobacco industry-sponsored reception and to negotiate a trade agreement that protects public health, not the tobacco industry. They should protect children and health around the world, not Philip Morris International, a company with a long history of targeting children, deceiving the public and opposing proven measures to reduce tobacco use and save lives."

The Rest of the Story

The rest of the story is that while the Campaign for Tobacco-Free Kids is excoriating government officials for potentially just attending a corporate reception sponsored by Philip Morris International, the Campaign for Tobacco-Free Kids itself participated in a secret negotiation with Philip Morris that resulted in a federal statute that drastically changed the nation's policy toward tobacco.

Thus, if the Campaign wishes to attack any organization for sitting down and negotiating tobacco policy with Philip Morris, it should begin the attack by blasting itself for being the worst example of doing exactly what it is decrying in its public statement.

The Campaign can, if it wants, argue that the negotiation with Philip Morris led to a positive achievement (I disagree vehemently, as my readers well know). Nevertheless, it stands as a hypocrite if it attacks others for merely attending a corporate reception sponsored by Philip Morris when the Campaign actually sat down and negotiated an entire national tobacco policy with the same company.

Why did the Campaign for Tobacco-Free Kids negotiate national tobacco policy with a company that it says has "a long history of targeting children, deceiving the public and opposing proven measures to reduce tobacco use and save lives."

Moreover, if Philip Morris has a long history of opposing proven measures to reduce tobacco use and save lives, then I guess we can safely conclude that the Family Smoking Prevention and Tobacco Control Act is not one of them. After all, Philip Morris strongly supported the Tobacco Act. It must, then, not be a measure that will reduce tobacco use and save lives.

It seems to me that the Campaign is caught between a rock and a hard place. If it admits that negotiating with Philip Morris is appropriate as long as the outcome is a good one for public health, then it has no business berating the government for attending a corporate reception sponsored by the tobacco company. If it believes, instead, that negotiating health policy with Philip Morris is inappropriate, then it should turn its attention to itself and criticize itself for doing exactly that.

Monday, February 27, 2012

A new study published in the journal Tobacco Control concludes that the proliferation of smoking quit lines and the greatly increased use of nicotine replacement therapy over the past two decades have not led to improvements in the rate of smoking cessation on a population level.

(See: Shu-Hong Zhu, Madeleine Lee, Yue-Lin Zhuang, Anthony Gamst, Tanya Wolfson. Interventions to increase smoking cessation at the population level: how much progress has been made in the last two decades? Tobacco Control 2012;21:110e118. doi:10.1136/tobaccocontrol-2011-050371)

The study used data from the National Health Interview Survey to examine trends in the population rates of smoking cessation during the period 1991-2010. The findings were as follows: "Cessation rates vary from year to year, but there is no significant upward trend for the whole period. Attempts to fit a linear trend for these two panels of data (weighted by the sample size for each survey year) found the slopes are slightly negative but not statistically significantly different from zero (r=-0.02, p=0.94, all smokers, and r=-0.17, p=0.50 for white smokers)."

The study concludes: "Most importantly, there is no consistent upward trend, which would be expected given the various interventions that have been implemented in the USA over the last two decades. This is a perplexing result."

The article offers several possible explanations for the study findings. Two of the most critical are: (1) "the true effects of interventions are much smaller than reported"; and (2) "an overemphasis on the power of medications to help smokers quit may lead them to think they cannot quit without the medications, lowering self-efficacy and reducing the base rate of quitting."

The Rest of the Story

The paper correctly notes that: "Pharmacotherapies such as nicotine patches are recommended as first-line quit-smoking aids in clinical practice guidelines." Despite the explosive increase in the promotion of these products for smoking cessation over the past two decades, there has been no improvement in population smoking cessation rates.

This research reinforces the findings of a previous study by Pierce et al., which came to the same conclusion (see: Pierce JP, Cummins SE, White MM, Humphrey A, Messer K. Quitlines and nicotine replacement for smoking cessation: Do we need to change policy? Annu Rev Public Health 2012; 33:12.1-12.16).

This research highlights a major problem in the anti-smoking movement: Because of the strong pharmaceutical company ties of the leading anti-smoking researchers and organizations, there has not been an objective assessment of the effectiveness of smoking cessation policy, and this has led to an over-emphasis on nicotine replacement therapy and an exaggeration of its benefits.

Not only has the obsession with nicotine replacement therapy and other smoking cessation drugs harmed the public's health by diverting attention away from more effective national approaches, but it has also harmed public health because, as the authors of the present study correctly note: "an overemphasis on the power of medications to help smokers quit may lead them to think they cannot quit without the medications, lowering self-efficacy and reducing the base rate of quitting."

It would be one thing if the flawed advice being given by the NIH expert panel on smoking cessation (i.e., every smoker should be treated with pharmaceutical agents unless specifically contraindicated) were due simply to an innocent mistake, such as lack of complete knowledge of the effectiveness of various smoking cessation strategies. However, I believe that this is not an innocent mistake. Instead, it is the direct result of financial conflicts of interest which have clouded the judgment of those making national recommendations, including the NIH expert panel on smoking cessation, whose recommendations have heavily influenced the anti-smoking movement and helped to produce today's overemphasis on the power of medications to help smokers quit.

Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the smoking cessation clinical practice guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.

These 9 panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.

Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:

Michael C. Fiore (panel chair): "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."

Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."

Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."

Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."

C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."

Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."

Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."

GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.

What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.

This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.

Ironically, it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable.

While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.

The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.

As my colleague Dr. Lois Biener of the University of Massachusetts Boston argued in an Associated Press article about the guideline, there is little if any "real-world evidence" that when used outside the context of clinical trials, drugs produce any long-term enhancement of smoking cessation, and certainly not the magnitude of benefit as suggested by those who are touting the importance of these drugs.

One national expert on smoking cessation who was not on the panel - John Polito - has suggested that the guideline is basically a "sales pitch" for the pharmaceutical industry, that the benefits of pharmaceuticals are overstated, that the value of quitting cold turkey is not considered, and that the recommendation to promote Chantix use is misguided and could cause harm.

Polito has really stated it better than I could and he is right on the mark. The guideline is basically a sales pitch for the pharmaceutical industry, and it demonstrates what corporations can buy through their payments to scientific experts.

What's most disturbing to me is that while the medical field continues to move to decrease the influence of pharmaceutical companies on physicians by restricting financial benefits for doctors, the tobacco control field seems to be increasingly plagued by this pharmaceutical influence. The problem is being ameliorated in medicine, but in tobacco control, it continues to get worse.

The ultimate irony of all of this is that we in tobacco control have been so vehement in decrying the tobacco industry's influence on science. We have attacked and berated scientists for having financial ties to tobacco companies. We have discredited scientific conclusions based solely on the financial connections of the authors to Big Tobacco. But now, our national policies are being set by individuals who have equally strong connections to Big Pharma.

It may come as a surprise to many in tobacco control, but this type of science is just as bad. Bad science is bad science. Conflicts of interest are conflicts of interest. Believe me, the science doesn't get any stronger just because it is a less detestable industry. As a field which has literally helped to ruin the careers of scientists with tobacco industry connections, we should be beyond reproach in not allowing similar conflicts of interest to degrade and poison our science.

Thursday, February 23, 2012

According to an article in the Deseret News, a Utah health official has touted as a benefit of regular cigarettes the fact that at least consumers know how much nicotine they are getting, in contrast with electronic cigarettes which the official contends will lead to ex-smokers just vaping away because they don't know how much nicotine to take in. The remarks were apparently made in the context of supporting a proposed state law that would ban the use of electronic cigarettes in public places.

According to the article: "Last summer, the Utah Department of Health adopted a rule banning the use of hookah and e-cigarettes in public places but has not enforced the rule awaiting legislative action on the issue. Manufacturers of electronic cigarettes claim the battery-powered device is safer than cigarettes, which use tobacco. However, according to the U.S. Food and Drug Administration, e-cigarettes contain harmful levels of nicotine, a substance the agency classifies as a stimulant drug. "There is no safe level of tobacco smoke," said David Neville, spokesman for the Tobacco Prevention and Control Program at the Utah Department of Health. With tobacco cigarettes a user generally knows how much nicotine is being consumed. "They know if they are a half-a-pack-a-day smoker. When it comes to an electronic cigarette, you just don't know. You just keep on smoking," Neville said. The measure, which passed on a 45-31 vote, now moves to the Senate."

The bill would add electronic cigarettes to the state's existing ban on smoking in public places.

The Rest of the Story

This story demonstrates how ridiculous the arguments of anti-smoking advocates have become in trying to attack electronic cigarettes. They are now actually defending the real ones in an effort to cast dispersions on the much safer electronic ones.

Is the Utah Department of Health serious about this? Is it truly an advantage of cigarettes that the user knows exactly how much he is smoking? Should ex-smokers who have quit using e-cigs discontinue their use of electronic cigarettes and return to cigarette smoking because they are better off knowing how much nicotine they are getting?

This is the kind of blind ideology that is taking over the anti-smoking movement and which clouds our decision-making ability. Instead of seeing the broader picture and understanding that use of electronic cigarettes in most cases leads to drastic reductions in health risks because the users are either quitting smoking or greatly decreasing the amount they smoke, we are getting stuck up on the concern that we can't translate electronic cigarette use into cigarette pack equivalents?

Moreover, unless the health official's comment was taken out of context, his argument that there is no safe level of tobacco smoke is irrelevant to the issue of banning electronic cigarettes, because e-cigarettes do not produce any tobacco smoke. Or smoke of any kind. In fact, the argument that there is no safe level of tobacco smoke should lead one to support an intervention (e-cigarettes) which, by definition, reduce the amount of tobacco smoke exposure for the user.

The rest of the story is that ideological arguments are now starting to take the place of scientific arguments in the anti-smoking movement. And the result is that the public's health is no longer being served. In some cases, the resulting policies and actions are actually causing public health harm.

Wednesday, February 22, 2012

A study published online ahead of print in the American Journal of Public Health reports the results of a survey of public opinions regarding cigarette regulation. The primary finding was that the overwhelming majority of the public supports regulations that would mandate substantial reductions in the amount of nicotine in cigarettes, reductions that the authors claim would bring nicotine to a "non-addictive level."

According to the press release accompanying the article: "A vast majority of U.S. adults support reducing nicotine in cigarettes to below nonaddictive levels if it means fewer children and adults will become addicted to cigarettes, according to a new study led by Harvard School of Public Health (HSPH) researchers. The study was published online February 16, 2012 in the American Journal of Public Health. ... Lead author Gregory N. Connolly, director of the HSPH’s Center for Global Tobacco Control, and Hillel Alpert, research scientist and senior author, and colleagues conducted a nationally representative public opinion survey of 511 nonsmokers and 510 smokers adults aged 18 and older, excluding Hawaii and Alaska, from May 18, 2011 through June 5, 2011. ... Among the findings:

More than 3 in 4 persons (77%), including 81% of nonsmokers and 74% of smokers, supported the reduction of nicotine in cigarettes to levels below the threshold of addiction if it could cause fewer children to become addicted to cigarettes.

Nearly 2 in 3 (65%) persons supported reducing nicotine in cigarettes to nonaddictive levels, including 73% of nonsmokers and 58% of smokers."

The article concludes: "The FDA should consider protecting children by removing all but nonaddictive cigarettes from the marketplace."

The Rest of the Story

There's just one problem with this story. What is the "non-addictive level" of nicotine? What is the threshold level of nicotine in cigarettes, below which cigarettes are not addictive?

Unfortunately, we simply do not have the science base to support the contention that there is a specific threshold level of nicotine, above which cigarette smoking is addictive and below which cigarette smoking is not addictive.

It may be, for example, that there is no specific threshold for the addictive nature of cigarette smoking. Remember that smoking is not just a pharmacologic addiction, but a behavioral and social addiction as well. It is possible that even in the absence of nicotine, cigarette smoking could still be addictive.

In fact, there is evidence to support this contention. A large number of electronic cigarette smokers are maintaining themselves on zero nicotine cartridges. Yet they continue to rely upon the use of electronic cigarettes. In other words, they are still addicted to "vaping," yet they are not inhaling any nicotine. The behavioral aspects of the cigarette smoking process cannot be ignored.

Moreover, it may be that even minute quantities of nicotine are enough to occupy sufficient nicotine receptors in the brain to cause some level of addiction. The idea of non-addictive levels of an addictive substance is not something that has been previously recognized in addiction science. For example, has any scientist proposed that there is a level of heroin below which it is not addictive? Are there non-addictive levels of cocaine? Are there non-addictive levels of benzodiazepines?

An even bigger problem is that by reducing the levels of nicotine in cigarettes, the FDA might actually be increasing cigarette-related disease. How so? Since smokers need to maintain a consistent dose of nicotine, a substantial reduction in dose would result in significant amounts of compensation, meaning that smokers would inhale more deeply and smoke more of the low-nicotine cigarettes mandated by the FDA. This would result in a major increase in tar exposure (that is, exposure to carcinogens and lung and heart toxins), resulting in increased rates of heart disease, lung disease, and cancer.

The rest of the story is that the issue is not as simple as this research would have us - and the public - believe. Congress was very careful in crafting the Tobacco Act to ensure that no major actions would be taken by the FDA that would substantially threaten cigarette sales. One of these actions was to prohibit the FDA from eliminating nicotine from cigarettes. The agency cannot require the companies to reduce nicotine below practicable levels, and there is no scientific certainty that the lowest practicable level of nicotine is a non-addictive one.

Reducing nicotine in cigarettes could be a great public health victory, or it could be a complete disaster. We simply don't know at this point. But one thing is for sure. The issue is not as simple as anti-smoking groups have made it out to be.

Tuesday, February 21, 2012

An article in Saturday's National Post considers the issue of whether smoking bans in wide-open outdoor areas such as parks go too far. The issue is now of interest in Canada because a number of municipalities have enacted or are debating outdoor smoking bans. For example, Barrie, Ontario, Cornwall, Ontario, Belleville, Ontario, Squamish, British Columbia, Vancouver, British Columbia, Bridgewater, Nova Scotia, and Kentville, Nova Scotia have all banned smoking completely in all city parks.

According to the article:

"Dr. Michael Siegel has been an anti-smoking advocate for 25 years, even testifying as an expert witness in a U.S. lawsuit that slapped the tobacco industry with a $145-billion verdict. He has stood before Congress and fought for smoking bans in restaurants, bars and casinos, and he supports smoke-free playgrounds because they are designed specifically for children."

"Today though, Dr. Siegel is breaking ranks with his own movement because he fears it has gone too far, jeopardizing itself from within by crusading for bans in even the largest of outdoor public places such as parks and beaches."

"By treading into the realm of Times Square or Stanley Park, as New York and Vancouver have done, the movement risks losing the science-based argument it has long won — because, Dr. Siegel said, there is no evidence that fleeting second-hand exposure in an open space is significantly harmful."

"'Once we leave the firm ground of science, we could be viewed as zealots — fanatics trying to eliminate smoking anywhere and everywhere,' said Dr. Siegel, a professor at the Boston University School of Public Health."

Also according to the article: "The Canadian Council for Tobacco Control says ... that even passing exposure to second-hand smoke is harmful."

The Rest of the Story

This is an issue that I have discussed at length here at the Rest of the Story, so it is nice to see the issue getting some attention in the media. The problem, exposed by the article's citation of a statement from the Canadian Council for Tobacco Control asserting that even fleeting exposure to secondhand smoke is harmful, is that the tobacco control movement appears to be straying from its science base.

It's one thing to argue that bar and restaurant workers who are exposed to high levels of secondhand smoke for 40 or more hours per week are at risk of suffering significant health problems because of that exposure. We can back that up with strong scientific evidence. However, it is quite another thing to assert that fleeting secondhand smoke exposure - such as occurs in public parks - is a major public health problem requiring government intervention. Moreover, it's difficult for me to understand why an affected nonsmoker who might be sensitive to the acute effects of secondhand smoke could not simply walk away from a smoker in a park.

By asserting that fleeting exposure to secondhand smoke is a substantial health risk, are we not inadvertently making a mockery of the very strong case we have put together to argue that chronic secondhand smoke exposure, such as that experienced by bar, restaurant, and casino workers, is a huge hazard - one from which the government must protect workers by banning smoking in these environments?

What's the point of putting together a strong case of scientific evidence and studies to support our efforts to promote workplace smoking bans if we are going to, at the same time, put forward the argument that even a whiff of secondhand smoke is a significant health hazard?

Why the need to do research on the effects of secondhand smoke in the first place if we are going to put forward the argument that all it takes to significantly harm your health is a single whiff of secondhand smoke? If that assertion is true, then much of my career's work has been a waste of time. What contribution did my research make? It documented that bar and restaurant workers face higher lung cancer risks because of their high exposure to secondhand smoke. But what does that matter if merely a fleeting exposure to secondhand smoke is significantly harmful?

Moreover, if all it takes to significantly harm health is a passing exposure to secondhand smoke, then what justification is there for allowing smoking anywhere outside? Why are not these same advocates calling for complete bans on smoking in all outdoors locations? Why just restrict the bans to public parks and beaches? What about crowded streets and sidewalks? Outdoor malls? Busy outdoor shopping areas? Parking lots? The outdoor grounds of hospitals and doctors' offices? Outdoor areas of college campuses?

What I fail to understand is how public health advocates who truly believe that fleeting secondhand smoke exposure is a substantial public health problem can justify their own failure not to promote or advocate for or support complete bans on outdoor smoking, which would include all of the above locations? It seems to me that there is a major inconsistency in their argument.

The rest of the story is that by putting forward this inconsistent treatment of secondhand smoke exposure, and by moving away from a strong science base and towards the arena of fanaticism, I'm afraid that we are risking the erosion of the scientific and policy legitimacy that we worked so hard to establish. And this could make it much more difficult to pass smoking bans where they are truly needed to protect people's very lives: in bars, restaurants, and casinos in the many states which still have not taken steps to protect these workers' ability to make a living and support their families without having to breathe in carcinogens for 40+ hours a week at their places of employment.

Thursday, February 16, 2012

Yesterday, I reported on a new study from the Rhode Island Department of Health which concluded that the smoking ban, implemented in Rhode Island in March 2005, resulted in a 28% drop in heart attack admissions in the state (see press release).

The study examined age-adjusted rates of admission for acute myocardial infarction in all Rhode Island hospitals from 2003 to 2009. The report compares the hospitalization rates in 2003 and 2004 (prior to the smoking ban) with those in 2006 through 2009 (the four complete calendar years following the smoking ban).

According to the press release: "The findings reveal a 28.4 percent drop in the rate of acute myocardial infarction (AMI) admissions and a 14.6 percent reduction in total associated cost, representing a potential savings of over six million dollars."

However, as I showed, an examination of the actual data reveals that before the smoking ban, heart attacks were declining at 10.5% per year and after the smoking ban, heart attacks were only declining at 5.3% per year. Thus, when viewed in light of the baseline trend, there is no evidence that the Rhode Island smoking ban led to a decline in heart attack admissions.

The paper, however, concluded that the smoking ban led to a 28.4% decline in heart attacks. If you're wondering where this 28.4% number comes from, the paper simply determined the change in heart attacks from 2003 to 2007.

The Rest of the Story

In other words, the paper made no attempt to control for, or even consider baseline trends in heart attacks in Rhode Island, which were declining rapidly prior to the smoking ban. This is a cardinal error which renders the conclusions of the study invalid.

When one runs a regression analysis that controls for the secular trend of declining heart attacks (which existed before the smoking ban), one finds that the coefficient for the effect of the smoking ban is no longer statistically significant. Basically, what this means is that although there was a significant decline in heart attacks in Rhode Island from 2003 to 2009, this decline was not significantly different from what would have been expected based on the rate of decline in heart attacks that was already occurring in the state prior to the smoking ban.

Here are the heart attack rates reported in the study. The smoking ban was implemented in March 2005, so the data for 2005 should begin to reflect any effect of the smoking ban:

The study analyzes the data as if the heart attack admission rate in 2004 was also 35.2, just as in 2003. In other words, it assumes that the heart attack rate was steady at baseline. Were that the case, then one could simply report the percentage change in heart attacks from 2003 to 2007 and attribute that to the smoking ban, as the study did.

However, the heart attack rate in 2004 was not 35.2. It was 31.5. This represents a 10.5% decline. And it was already occurring: prior to the smoking ban. One needs to control for this baseline secular trend of declining heart attacks in the baseline period in order to determine whether the smoking ban had any effect. Otherwise, one is simply reporting the pre-existing secular change. This is precisely what the Rhode Island report did.

When you are examining an outcome measure that is changing over time, one must account for the pre-existing trends in this variable before attributing these changes to an outside factor. Failure to do this renders the conclusions invalid.

What I can't seem to understand is why nearly every smoking ban - heart attack study appears to be making the same analytic mistake. It is as if anti-smoking researchers are only interested in reporting favorable results, rather than in reporting accurate ones.

Wednesday, February 15, 2012

A new study from the Rhode Island Department of Health has concluded that the smoking ban, implemented in Rhode Island in March 2005, resulted in a 28% drop in heart attack admissions in the state (see press release).

The study examined age-adjusted rates of admission for acute myocardial infarction in all Rhode Island hospitals from 2003 to 2009. The report compares the hospitalization rates in 2003 and 2004 (prior to the smoking ban) with those in 2006 through 2009 (the four complete calendar years following the smoking ban).

According to the press release: "The findings reveal a 28.4 percent drop in the rate of acute myocardial infarction (AMI) admissions and a 14.6 percent reduction in total associated cost, representing a potential savings of over six million dollars."

The study also examined changes in hospital admission rates for asthma and appendicitis. Asthma was chosen because it is also related to secondhand smoke. Appendicitis was chosen as a control condition because it is not related to secondhand smoke exposure.

The study results were as follows: "The largest reduction in AMI hospitalization rates was seen between 2003, when the rate was 35.2 per 10,000 population (95% CI 34.0 – 36.5), and 2009, when the rate was 23.1 per 10, 000 population (95% CI 22.1 – 24.1), a full four years after the ban prohibiting smoking in public places took effect. There was a significant increase in hospitalization rates for asthma between 2003 (11.3; 95% CI 10.6 – 12.1 and 2009 (13.5; 95% CI 12.8 – 14.3), but no change in the hospitalization rate for appendicitis over this time period (2003: 7.9; 95% CI 7.3 – 8.5; 2009: 8.5; 95% CI 7.9 – 9.1)."

The study then concludes: "Our study showed a reduction in age-adjusted hospitalization rates for AMI after the implementation of a statewide comprehensive ban on indoor smoking, with a 17% reduction in AMI-specific hospitalization rates in the first post-statewide ban period (2006-2007). A strength of this study is that we assessed the potential effects of the ban in the two years immediately following its implementation and at one later time point, which showed sustained decreases in AMI hospitalization rates and associated costs."

The media are now reporting that Rhode Island's smoking ban led to a huge decline in heart attack admissions.

The Rest of the Story

The rest of the story is that the actual study data show that the heart attack admissions rate in Rhode Island was declining significantly prior to the smoking ban. The analysis fails to take this into account, because rather than examine the significance of the difference between the rate of decline in heart attacks after the ban and the rate of decline prior to the ban, it merely compares the absolute rates of admissions before and after the ban. Thus, it does not control for the baseline, pre-existing trend of a huge secular decline in heart attacks observed in Rhode Island during the years immediately preceding the implementation of the smoking ban.

In other words, while the study finds a 28% decline in heart attacks, what percentage decline in heart attacks would one have expected in the absence of the smoking ban? The best answer to that question comes from examining the baseline data. Unfortunately, the paper only goes back two years before the smoking ban so the only years that can be used to estimate the rate of decline in heart attacks prior to the smoking ban are the 2003 and 2004 data points. Nevertheless, these are the data that must be used.

Here is what you'll find if you examine the actual difference in the observed average annual rate of decline in heart attacks before and after the smoking ban:

Before Ban: 10.5% per yearAfter Ban: 5.3% per year

In other words, the actual data show a deceleration, or a decrease, in the rate of decline in heart attacks in Rhode Island in the years following the smoking ban.

The figure below plots the actual data.

It is clear from the graph that the rate of decline in heart attacks decelerated somewhat after the smoking ban. Had the decline continued following the baseline trend, the expected heart attack rate in 2009 would have been 18.1, instead of the observed rate of 23.1.

One of the major problems with this study is that it does not examine enough pre-smoking ban data to reliably establish the baseline trend in heart attacks. But given the data that is available, one is forced to conclude that there was a deceleration in the rate of decline in heart attacks.

The rate of decline in heart attacks in the year prior to the smoking ban (10.5%) is larger than the year-to-year decline in heart attacks for any period following the smoking ban. In fact, from 2007 to 2008, there was actually a slight increase in the heart attack rate. Given these data, it is difficult to see how the paper could conclude that the smoking ban resulted in a 28% decline in heart attacks.

More troubling, perhaps, is the way the paper dismisses the failure to find a decline in asthma admissions following the smoking ban. On the contrary to what one might have expected, the study reports an increase in asthma admissions. Since the study concluded that the observed changes in heart attacks were attributable to the smoking ban (and does not consider any other factors), must not the paper also conclude that the changes in asthma attack admissions were also attributable to the smoking ban?

Instead of using the same reasoning it used to attribute changes in heart attacks to the smoking ban, the paper dismisses this "adverse" result and explains it away based on conjecture about changes in the economy: "The severity of the recent economic crisis in Rhode Island likely amplified factors associated with asthma exacerbations, such as poverty and poor housing quality. These factors may have contributed to the increase in hospital admissions for asthma."

Unfortunately, this has the appearance of accepting as a causal relationship any favorable changes following a smoking ban, but rejecting a causal link for any unfavorable changes following the smoking ban. In other words, the research appears to be heavily biased in the direction of interpreting results in order to be able to report favorable findings and not having to report any unfavorable findings.

To be clear, I am not arguing that the smoking ban resulted in an increase in asthma. Nor am I arguing that the smoking ban resulted in an increase in heart attacks. What I am arguing is that based on the data presented in the paper, there is no way the article can conclude that the Rhode Island smoking ban was associated with a 28% decline in heart attack admissions in the state.

In order to make any causal attributions at all, one would first have to extend the baseline back at least four to five more years to get an accurate picture of the baseline trends in heart attacks and asthma rates prior to the smoking ban.

While I strongly agree with the paper's recommendation that other states "join the growing list of 35 U.S. states benefiting from smoke-free laws," my support for such policies is not based on the finding that the Rhode Island smoking ban decreased heart attacks by 28%. While we all want to see a positive and immediate effect of these policies on severe morbidity, being scientifically rigorous is still important and it does not help the cause in the long run to draw conclusions that are unsupported by the data. There are enough reasons for policy makers to enact smoking bans. There is no need for us to try to artificially manufacture findings that are unsupported by the data.

Tuesday, February 14, 2012

One of the deeply ingrained pieces of dogma that I was taught as a young anti-smoking advocate is that the cigarette companies are never right. Everything they say is false, every argument they make is invalid, and we in tobacco control are always right.

To be sure, there is still a lot that the tobacco companies say that is not right. For example, the continuation of their arguments in the courtroom that a particular smoker's lung cancer is not causally related to his smoking is generally a futile effort that doesn't fool anyone in 2012. I think the companies have the right to argue that they should not be held responsible for the decision of an adult smoker to smoke, but to argue against the connection between smoking and lung cancer in 2012 does not help companies that are trying to re-shape their public image.

However, CNN's Bob Greene highlighted on Sunday an area where I agree that the tobacco companies have it right: requiring companies to place graphic warning labels on their products which exhort their own customers not to use the products and which provide a special toll-free smoking cessation number is an infringement on these companies' free speech rights. It goes beyond the simple provision of factual and uncontroversial information and enters the realm of coercing speech intended to persuade consumers not to use the product.

Greene writes: "No matter how much many of us may dislike what cigarettes have done to the nation's health, the First Amendment argument is a compelling one. The government risks setting a troubling precedent when, regardless of how laudable the intentions, it tells someone -- either a person or a company -- that it must say and show things that aggressively advocate against the person's or company's own interests. That's the slipperiest of slopes to start sliding down. What about the text-only warning labels that have appeared on packs of cigarettes for decades? The cigarette companies have never liked them either, of course. But the argument in court is that there is a legal distinction between requiring labels that state facts and requiring illustrations that serve to actively advocate against the purchase of the product. "

The Rest of the Story

Despite being a staunch anti-smoking advocate, I agree with the cigarette companies' basic argument that compelling them to advocate against the use of their own products goes beyond any government interest in ensuring that consumers have adequate factual information about the risks of a consumer product.

Moreover, even if the level of scrutiny is lowered and the Central Hudson test is employed, it is impossible to argue that requiring these warning labels is the most narrowly tailored intervention that the government could propose to advance its purpose.

While I've previously put forward my opinions on this case, what I want to focus on today is what expressing these opinions means for me. Because the dogma in the anti-smoking movement is that the cigarette companies are never right (and we always are), this opinion of mine is political suicide from the perspective of being a part of the anti-smoking movement.

Very few, if any, other anti-smoking advocates, regardless of their actual position on the legal issues, will publicly disagree with the Department of Justice's position. This type of dissent from the dogma of the anti-smoking movement is viewed as heresy.

As with disagreement with scientific issues, there is only one way of looking at legal issues in the anti-smoking movement and that is on the side of the anti-smoking groups.

What the tobacco control movement needs to realize, however, is that failing to base our opinions on the actual scientific and legal issues puts us in the same historical camp as the very companies we have criticized. Once we reject evidence-based science and policy in favor of one-sided dogma, we have left the realm of public health and entered the area of partisan politics. Sure, we may be on the health side of the issue, but we're still playing politics.

Monday, February 13, 2012

The manager of the Tobacco Prevention and Control program for the Utah County Health Department argued in an op-ed column last week that electronic cigarettes should be banned because they contain toxic chemicals and carcinogens, according to an FDA laboratory report. The column was a response to an editorial published in the Daily Herald which argued against banning the use of electronic cigarettes in public places, a move being considered by Utah's legislature.

In the editorial, the Daily Herald argued that electronic cigarettes, although not fully studied, do not contain or burn tobacco and are almost certainly safer than regular smoking. Therefore, they are advantageous as an option to help smokers quit, even if they maintain themselves on electronic cigarettes. Why, asks the paper, would public health advocates want to put forward an obstacle that makes it more difficult for smokers to quit? The paper goes so far as to question whether the proponents of the proposed electronic cigarette ban are really supporting the public's health.

In response, the manager of the Utah County Health Department's anti-smoking program - Toni Carpenter - argues that electronic cigarettes do expose vapers to toxic chemicals and carcinogens, citing an FDA laboratory study.

She writes: "the Daily Herald mentioned electronic cigarettes 'do not foul the lungs with harmful carcinogens and toxins.' However, preliminary analysis by the U.S. Food and Drug Administration showed that the e-cigarettes sampled contained detectable levels of carcinogens and toxic chemicals to which users could potentially be exposed. For example, diethylene glycol (an ingredient used in antifreeze) was detected in one of the cartridges sampled and certain tobacco-specific nitrosamines, which are human carcinogens, were detected in half of the samples tested."

She then suggests that electronic cigarettes should be banned, as she cites the fact that: "E-cigarettes are being banned across the world in countries such as Australia, Canada, Singapore and Brazil."

For smokers who want to quit, the tobacco control program manager recommends the use of nicotine replacement therapy, such as nicotine patches and nicotine gum.

The Rest of the Story

Carpenter asks the question: How could we possibly allow on the market a product (electronic cigarettes) which contains detectable levels of carcinogens?

I now ask the question: How, then, could this public health official possibly recommend the use of a product (nicotine gum and patch) which contains carcinogens?

You see, the rest of the story - apparently unknown to this anti-smoking advocate - is that nicotine patches and nicotine gum, like electronic cigarettes, contain detectable levels of carcinogens (specifically, tobacco-specific nitrosamines [TSNAs]).

It turns out that since nicotine is extracted from tobacco, trace amounts of TSNAs appear in virtually all nicotine-containing products, including electronic cigarettes, nicotine patches, and nicotine gum. The level of TSNAs in electronic cigarettes is comparable to that in NRT products. Thus, from the perspective of TSNA levels, if Carpenter believes electronic cigarettes should be banned, then so too should all other NRT products.

However, it turns out that there is an additional source of carcinogens in nicotine gum users which is not a factor in vapers. A a recent study published online ahead of print in the journal Cancer Research reports that the use of nicotine gum is associated with significant exposure to a potent carcinogen and concludes that oral nicotine replacement therapy (NRT) use therefore poses a potential carcinogenic hazard to some users.

The same problem was not detected with the nicotine patch. Since the study concludes that the carcinogens were likely formed in the stomach, the problem would also not be expected to occur with the use of nicotine inhalers or electronic cigarettes.

In the study, urine levels of NNN - a potent carcinogen - were measured at baseline in smokers. Then, the smokers quit smoking by using either nicotine patches, nicotine gum, or nicotine lozenges. The group was followed for a period of two months after quitting smoking, with periodic follow-up measurements of NNN in their urine.

The major results and conclusion of the study was as follows:

"In 13 of 34 nicotine gum or lozenge users from both studies, total NNN at one or more time points after biochemically confirmed smoking cessation was comparable to, or considerably higher than, the baseline levels. For most of the subjects who used the nicotine patch as a smoking cessation aid, urinary total NNN at all post–quit time points was <37% of their mean baseline levels."

Of note, experts estimate that 36.6% of nicotine gum users are long-term users. Thus, these concerns are not just hypothetical ones.

Because the authors suggest that the NNN is being formed endogenously in the stomach in association with oral NRT use (this would explain the absence of this NNN problem in nicotine patch users), one would surmise that nicotine inhalers and electronic cigarettes do not pose similar problems of significant carcinogenic exposure to users due to the endogenous formation of NNN.

Given this finding that oral NRT users may experience significant carcinogenic exposure and that this exposure could persist over long periods of time due to the way these products are commonly used, the question is: Why aren't the same anti-smoking groups which are calling for the removal of e-cigarettes from the market also calling for the removal of oral NRT products?

How can the Campaign for Tobacco-Free Kids, the American Heart Association, the American Lung Association, Action on Smoking and Health, and the American Legacy Foundation justify their calls for a ban on electronic cigarettes - which have not been shown to pose any carcinogenic hazard - while they remain silent about the risks of oral NRT use - which has now been shown to pose a significant carcinogenic hazard in a substantial proportion of users?

Clearly, there is a need for more research on these products, as suggested by the study authors. But why allow the product to remain on the market while these studies are conducted? If your attitude is that e-cigarettes must be taken off the market until further studies are conducted, then why should oral NRT products remain on the market during those same studies?

Let me make a clear distinction, however, between oral NRT products and electronic cigarettes. In the first case, there is clear evidence of a significant carcinogenic exposure that could potentially put users at risk, especially the 36.6% who use the product long-term. In the second case, there is not any evidence of a carcinogenic hazard, or any other hazard for that matter (other than the effects of nicotine itself, which is the same in all of these products).

It is all well and good to say: "We don't know if electronic cigarettes are safe. We should ban them until we know they are safe." But that's an uninformed opinion. There is plenty of scientific evidence out there already about the safety of the product. It has been studied extensively in the laboratory and its chemical components have been characterized. In fact, we know far more about the chemical components of electronic cigarettes than we do about the components of Marlboros. Moreover, the question is not whether electronic cigarettes are "safe." The question is whether they are substantially safer than tobacco cigarettes.

Policy needs to be based on science, not pure conjecture. Let's look at the science. Based on the studies that have been done and the information about adverse effects of the product during its 3 years of use in the United States, as well as the characterization of the components in the product, what are the specific chemical exposures occurring among vapers and non-vapers that these anti-smoking groups posit may pose a significant health hazard?

If these groups cannot name a potential specific hazard, then it seems imprudent to ban the product, take it off the market, or even to ban its use in public, as this is going to result in forcing large numbers of vapers to go back to cigarette smoking.

You see, the anti-smoking groups have it all wrong. They are arguing that we need to ban the product because it is possible that it could be having an adverse effect on users (or non-users) and so to be safe and make sure that we are not causing harm, we need to carry out more studies (of course, they have not specified what studies are needed, since we already have 3 years of use of the product with no reported adverse effects).

Instead, I argue that to remove the product from the market, or even to ban its use in public, would result in a known and definite public health hazard: thousands of vapers returning to cigarette smoking, which is without doubt going to cause disease and death.

Public health is about reducing disease and death, not increasing it because of scientific uncertainty. Scientific uncertaintly is always going to be present to some degree. We cannot let that uncertainty get in the way of making rational decisions and we certainly cannot allow it to make us forget the information that we do have. And the information that we do have clearly suggests that pulling e-cigarettes off the market would do a lot more harm than good.

Based on the current evidence available, it is very clear to me that allowing ex-smokers to continue using electronic cigarettes, even in public places, is in the best interests of the public's health. Forcing them to return to cigarette smoking is the last thing in the world that public health groups should be doing.

Thursday, February 09, 2012

For the first time, the Centers for Disease Control and Prevention (CDC) has called for state and local governments to ban smoking in cars with children present.

In an article published online ahead of print in the journal Pediatrics, researchers from the Office on Smoking and Health at CDC examined trends in the prevalence of self-reported exposure to secondhand smoke (SHS) in cars among youths, based on data from the National Youth Tobacco Survey.

The results and conclusion of the study were as follows: "SHS exposure in cars decreased significantly among U.S. middle and high school students from 2000 to 2009. Nevertheless, in 2009, over one-fifth of nonsmoking students were exposed to SHS in cars. Jurisdictions should expand comprehensive smoke-free policies that prohibit smoking in worksites and public places to also prohibit smoking in motor vehicles occupied by youth."

The Rest of the Story

To the best of my knowledge, this is the first time that CDC has supported government bans on smoking in cars with children present. There is a problem with such policies, however. Secondhand smoke exposure in the home is much more important as a source of childhood morbidity than exposure in cars. First, secondhand smoke exposure in the home is much more prevalent than exposure in cars. Second, the duration of exposure in the home is orders of magnitude higher than that in cars. Thus, the morbidity burden related to secondhand smoke in the home greatly exceeds that related to secondhand smoke exposure in cars. However, the CDC is not recommending a ban on smoking in homes with children.

It seems hypocritical for CDC to suggest that governments should ban smoking in cars to protect children from a major public health hazard, but that governments should not similarly ban smoking in the home. This is especially problematic as a policy stance because the morbidity associated with secondhand smoke in the home dwarfs that related to the usually brief exposure to secondhand smoke that occurs in cars. While children may be exposed to secondhand smoke in cars for thirty minutes or an hour a day, they may well be exposed to tobacco smoke in the home for as much as eight to ten hours a day.

What, then, is the justification for banning smoking in cars but not in the home?

Unfortunately, I have not been able to find such a justification. If one is willing to say that interference with parental autonomy in a private car is justified because of the magnitude of the public health burden associated with smoking in cars, then it is even more true that interference in the home is justified. Therefore, I don't see how the CDC, or any tobacco control group, could justify banning smoking in cars but not in homes with children present. If anything, banning smoking in the home would be more important and easier to justify because the duration of exposure is huge and health effects are much more likely to result.

While the CDC's recommendation that localities ban smoking in cars with children may prevent these youth from exposure during the minutes they are in a car, it will not spare them exposure during the hours upon hours that they are in the home. Thus, these policies are likely to have minimal public health impact (unlike a home smoking ban, which would have a major health impact).

If the CDC and other public health groups are sincere about standing up to protect the health of children, and if they are willing to interfere with parental autonomy in private vehicles by banning smoking in those vehicles, then why are these groups not proposing or supporting bans on smoking in the home? After all, the home - not the car - is the greatest source of secondhand smoke exposure for children who live with smokers.

Those who argue that the worst exposure is in the car are mistaken, as they are confusing concentration of exposure with dose. The dose of exposure is equal to the concentration of exposure multiplied by the duration of exposure:

Dose = Concentration x Duration

While the concentration of secondhand smoke in cars can be very high, the duration of this exposure is short compared to the duration of exposure in the home. And you can bet that if parents are smoking in cars with children, they are most likely also smoking in the home.

By not supporting a ban on smoking in homes with young children, I believe that these politicians, policy makers, and anti-smoking groups are actually being hypocritical and displaying a lack of sincerity, as well as a subordination of public health protection to politics.

My own position is that although smoking in cars with children is unfortunate, the government should not interfere with parental autonomy to make decisions about their children's health risks unless those risks are immediately life-threatening (such as not wearing a seat belt or car seat) or if the behavior causes harm to the child (e.g., abuse or neglect). I do not support smoking bans in the home for this reason. However, I also do not support bans on smoking in cars for the same reason. It would be hypocritical of me to argue for smoking bans in cars with children, but to oppose such policies in homes with children.

Sometimes the most difficult decisions in public health are ones in which we must accept the fact that many parents put their children at risk of health problems. We can still intervene to try to prevent this from happening with educational and persuasion campaigns, but coercive measures that interfere with parental autonomy when the child is not in a situation of direct, life-threatening risk or actual harm are not justified.

While the policy makers and health groups supporting the smoking ban in cars with children are well-intentioned, I believe they are also being insincere in their stated intention of protecting the health of these children. They want to protect them from high, but short-term exposure in cars, but they are perfectly willing to subject those kids to long-term exposure to secondhand smoke in the home.

The problem is that once you regulate the smoking behavior of parents in the presence of their children, you have asserted jurisdiction over the issue. If you fail to ban smoking in the presence of children in the home, you now share responsibility for subjecting children to this exposure. Why? Because you could have acted to prevent such exposure, but you failed to do so.

Tuesday, February 07, 2012

The Vice President of Public Policy of the Susan G. Komen for the Cure Foundation has resigned, amid controversy created by the Foundation's decision to rescind funding from Planned Parenthood, thus succumbing to political pressure from anti-abortion rights groups.

According to an article in the Boston Globe: "The vice president of public policy at Susan G. Komen for the Cure who backed the breast cancer charity's move to strip Planned Parenthood of funding resigned Tuesday, saying she stands by the now-abandoned decision that set off a storm of controversy. Karen Handel, who had denounced Planned Parenthood as a former gubernatorial candidate in Georgia, said in her resignation letter and later interviews that she was actively engaged in the efforts to cut off the grants."

Also according to the article: "Brinker [Komen Founder and CEO], in an interview with MSNBC last week, said Handel 'did not have anything to do with this decision.'"

In her resignation letter, Handel writes: "Neither the decision nor the changes themselves were based on anyone’s political beliefs or ideology. Rather, both were based on Komen’s mission and how to better serve women, as well as a realization of the need to distance Komen from controversy. I believe that Komen, like any other nonprofit organization, has the right and the responsibility to set criteria and highest standards for how and to whom it grants. What was a thoughtful and thoroughly reviewed decision - one that would have indeed enabled Komen to deliver even greater community impact - has unfortunately been turned into something about politics. This is entirely untrue. This development should sadden us all greatly."

The Rest of the Story

What should sadden us greatly is that even in her resignation letter, this top Komen official is deceiving the public about the reasons for the Foundation's decision to de-fund Planned Parenthood.

While Handel would have us believe that the real concern was loss of funding due to withdrawal of support from anti-abortion rights groups, the truth is that Handel used this as a strategy to try to convince the Board to de-fund Planned Parenthood. She exaggerated this threat strategically to advance what was clearly a politically-motivated decision.

According to a Huffington Postarticle: "Susan G. Komen for the Cure, the nation's leading anti-breast-cancer charity, has insisted that its since-reversed decision to pull funding from Planned Parenthood arose from a routine change in criteria for grant eligibility that had nothing to do with abortion politics. But a Komen insider told HuffPost on Sunday that Karen Handel, Komen's staunchly anti-abortion vice president for public policy, was the main force behind the decision to defund Planned Parenthood and the attempt to make that decision look nonpolitical."

"'Karen Handel was the prime instigator of this effort, and she herself personally came up with investigation criteria,' the source, who requested anonymity for professional reasons, told HuffPost. "She said, 'If we just say it's about investigations, we can defund Planned Parenthood and no one can blame us for being political.'"

"Emails between Komen leadership on the day the Planned Parenthood decision was announced, which were reviewed by HuffPost under the condition they not be published, confirm the source's description of Handel's sole "authority" in crafting and implementing the Planned Parenthood policy."

"Handel's strategy to cut off Planned Parenthood involved drafting new guidelines that would prevent Komen from funding any organization that was under investigation by local, state or federal authorities. Since Planned Parenthood is currently the target of a congressional inquiry prompted by House Republicans into the way it uses government funds, the family planning provider would have been immediately disqualified from receiving new Komen grants." ...

"Americans United for Life and other pro-life groups have been pressuring Komen for years to cut ties with Planned Parenthood because some of its clinics offer abortions, even though none of Komen's money was used toward abortion services. Handel's internal strategy, the Komen source told HuffPost, was to exaggerate those attacks and use them to convince the leadership that funding Planned Parenthood was a political liability."

"Komen's been dealing with the Planned Parenthood issue for years, and you know, some right-wing groups would organize a protest or send out a mailing every now and then, but it was on a low simmer," the source said. "What Karen's been doing for the past six months is ratcheting up the issue with leadership. Every time someone would even mention a protest, she would magnify it, pump it up, exaggerate it. She's the one that kept driving this issue." ...

"The source said Handel submitted a final version of the new grant criteria to Komen leadership in November, and the board approved it in December, at which point Komen's top public health official, Mollie Williams, resigned 'on the spot.' 'It was apparent to everyone in the organization that Karen was doing everything in her power to defund Planned Parenthood,' the source said, 'and that's why Mollie Williams quit.'"

Shame on the Komen Board for approving this politically-motivated attack on abortion rights. And shame on the Board for using such an underhanded tactic to carry out that attack: changing the funding criteria to disguise the real reason for the change in policy.

It is even more important to recognize that in itself, making funding decisions based on threats of withdrawal of funding by political groups is a political action. When breast cancer research funding decisions are made not on scientific grounds, but on grounds of what political groups might be offended by what organizations are receiving funding, then politics - not science - is guiding the funding decisions.

You see - this is what Handel sadly fails to realize. By arguing that her true motive was to protect Komen from losing money because of withdrawal of support by fringe political groups with an agenda, Handel was admitting that she was bringing politics into funding decisions. Making decisions about how to fund research and services based on what political groups might be offended is hardly an apolitical method of decision-making. In fact, it specifically brings politics into what should be a purely scientific discussion.

Would Handel also argue that refusing to fund organizations that provide services for gay people in order to appease ultra-conservative groups who oppose homosexuality is an example of ensuring the "highest standards for how and to whom it grants?"

Would she argue that refusing to fund organizations that serve African-Americans in order to appease Ku Klux Klan members who might not support Komen is an example of ensuring the "highest standards for how and to whom it grants" and is not a "political" decision?

Would she argue that the withdrawal of funding from groups that serve undocumented U.S. residents in order to appease organizations that want to deport all of these people is a decision designed to ensure the highest standards and has nothing to do with politics?

In asserting that "neither the decision nor the changes themselves were based on anyone’s political beliefs or ideology," this top-ranking Komen official is continuing to deceive the public, even in her own resignation letter. She is not fooling anyone. And frankly, she is making the situation a lot worse.

As Free Thought Blogsopines: "Things just get worse and worse for Komen. Though they reversed their terrible decision, it’s unlikely that they will ever fully recover from this self-inflicted wound."

What makes things worse still is that Handel's resignation letter makes it clear that Komen Founder and CEO Nancy Brinker lied to Komen's constituents and the public when she denied, in an MSNBC interview, that Handel had anything to do with the Planned Parenthood decision. It also makes it clear that Handel lied in the same interview when she argued that appeasing anti-abortion rights groups had nothing to do with the decision and that the decision was based solely on excellence in grant-making.

The Komen Foundation has destroyed its brand and is no longer a credible entity in the field of breast cancer research and services. The Foundation has not only made a politically motivated decision to throw women under the bus in order to succumb to pressure from anti-abortion rights groups, but even worse, it has blatantly lied to the public. In doing so, Komen has completely lost the public's trust. It will never recover from this self-inflicted wound, but its only chance of even partial recovery depends on its first admitting that it lied to the public.

According to an article in the Boston Globe, the Beth Israel Deaconess Medical Center is under federal investigation for overbilling Medicare. The investigation has been underway since 2010 and was disclosed over the last six months. According to lawyers familiar with the investigation, if true, these allegations represent fraud. If intentional, the overbilling is not simply a civil matter, but constitutes criminal wrongdoing, and the hospital could be subject to criminal penalties.

According to the article: "Federal investigators have subpoenaed six years of records from Beth Israel Deaconess Medical Center as part of an investigation into whether the hospital overbilled Medicare by admitting patients for short stays who could have been treated less expensively as outpatients. Beth Israel Deaconess received a subpoena from the office of the inspector general of the US Department of Health and Human Services and the US Department of Justice, in 2010, the hospital disclosed in financial statements over the last six months." ...

"Thomas Crane, a partner at Mintz Levin in Boston, said “fraud recovery is going to be a significant contribution’’ to paying for the expansion of insurance coverage in the country, according to financial estimates in President Obama’s affordable care act. ... Paul Enzinna, a lawyer with Brown Rudnick in Washington, said: “Any individual case is a judgment call. What Medicare is worried about is a person saying ‘my stomach hurts’ and the hospital admits the person.’’ Civil penalties may be imposed when overbilling results from an oversight, he said, but when it is found to be intentional, hospitals may be subject to criminal fines. “If a hospital is putting pressure on doctors to do this upcoding, that is clearly fraud,’’ Enzinna said."

The Rest of the Story

This is a federal investigation of Beth Israel that is criminal in nature, conclusive (whatever that means) and non-political. The Beth Israel Deaconess Medical Center is the recipient of a FY2011 grant from the Susan G. Komen for the Cure Foundation. Therefore, according to the grant policies announced last Friday by the Susan G. Komen for the Cure Foundation, Beth Israel is no longer eligible for Komen Foundation funding.

I therefore expect that the Foundation will be making an announcement tomorrow that it is withdrawing its grant from the Beth Israel Deaconess Medical Center. After all, as it stated last Friday: "Our original desire was to fulfill our fiduciary duty to our donors by not funding grant applications made by organizations under investigation."

Now we'll see whether the Komen Foundation was serious or whether it was just playing politics. Will it withdraw funding from the Beth Israel Deaconess Medical Center, as it now public knowledge that Beth Israel is the subject of a credible, non-political, criminal investigation by the federal government.

Obviously, the Komen Foundation is not going to rescind its funding of Beth Israel Deaconess. Why? Because it is not serious about this grant policy. The policy was never meant to be implemented across the board. It was designed as an excuse to de-fund Planned Parenthood. There was never any intention, I believe, of applying the policy equally across the board to all grantees. If there were, not only would grant funding have to be withdrawn from Beth Israel Deaconess, but it would also have to be withdrawn from Yale University, from Columbia University, from Penn State University, and from the University of California at Santa Cruz.

Unless the Komen Foundation announces tomorrow that it is withdrawing funding from the Beth Israel Deaconess Medical Center and these other university grantees, it will be clear to all that the revised grant policy was merely a hoax pulled on the public to make it look like the Foundation had a rational, fiduciary reason for its original grant policy, rather than the truth, which is that the Foundation implemented the policy specifically with an eye towards de-funding Planned Parenthood.

Ironically, the Komen Foundation's statement of last Friday emphasizes that politics should not play a role in the Foundation's activities: " We do not want our mission marred or affected by politics – anyone’s politics."

Sadly, the Foundation's mission continues to be marred by politics - its own politics. Despite the Foundation's rather weak attempt to disguise it, these politics are as obvious as an elephant in the room. And also sadly, there will continue to remain an elephant in the room for the Komen Foundation unless it comes forward and tells the truth about this sad affair. Breast cancer patients, Komen Foundation supporters, and women generally deserve nothing less.

I think that this quote from an article at AlterNet sums up the situation well: "This is already proving a disaster for the Komen Foundation. Once you institute an ideological litmus test for your funding decisions (and the group has no credibility on this front), people will begin to apply that same ideological litmus test to you. Now that the Komen Foundation has made it clear that their cancer research and prevention programs will be trumped by ideological motivations, I can't imagine why anyone wanting to donate money for anti-cancer efforts would not bypass them and give money directly to the groups that actually do that research and prevention."

Monday, February 06, 2012

Brand Will Not Be Restored Unless the Foundation Comes Clean; Organization is Still Practicing Politics, Not Public Health

After widespread public protest concerning its decision to withdraw breast cancer screening funding from Planned Parenthood, including an article last Thursday here at the Rest of the Story, the Susan G. Komen for the Cure Foundation reversed its decision and will restore funding to Planned Parenthood.

The decision was apparently made on Thursday evening in response to the massive outcry. A statement released by the Foundation on Friday announced the reversal of the decision, and attempted to explain what the revised policy will hold:

"We want to apologize to the American public for recent decisions that cast doubt upon our commitment to our mission of saving women’s lives. The events of this week have been deeply unsettling for our supporters, partners and friends and all of us at Susan G. Komen. We have been distressed at the presumption that the changes made to our funding criteria were done for political reasons or to specifically penalize Planned Parenthood. They were not."

"Our original desire was to fulfill our fiduciary duty to our donors by not funding grant applications made by organizations under investigation. We will amend the criteria to make clear that disqualifying investigations must be criminal and conclusive in nature and not political. That is what is right and fair. ... We will continue to fund existing grants, including those of Planned Parenthood, and preserve their eligibility to apply for future grants, while maintaining the ability of our affiliates to make funding decisions that meet the needs of their communities. ... We urge everyone who has participated in this conversation across the country over the last few days to help us move past this issue."

The Rest of the Story

Unfortunately, rather than a sincere apology, admission of wrongdoing, and honest attempt to move forward, the statement by the Komen Foundation appears to be a frantic attempt to save face in response to public outcry, but without having to take responsibility for what actually occurred.

It unfortunately has the effect of prolonging the controversy, continuing (and deepening) the deception, keeping murky the Foundation's separation of health and politics, and preventing the Foundation and its affiliates from moving forward and being able to concentrate on their actual mission.

Plus, the "clarification" of this new policy is itself problematic and untenable and creates more questions than it answers.

Most importantly, the Foundation failed to take responsibility for its politically-motivated decision to use the Stearns investigation of Planned Parenthood as an opportunity to rid itself of Planned Parenthood grants without having to make it look like a political decision. The Foundation apparently thought that by citing a new policy of fiduciary responsible grant-making, it could appease anti-abortion groups but without appearing as if the decision was politically motivated. Instead, the Foundation could argue that it would have liked to retain that funding, but it simply can't because it violates the rules.

However, it is quite clear that the funding rule was changed specifically because the Foundation saw an opportunity to rid itself of its relationship with Planned Parenthood in order to appease conservative anti-abortion groups.

Among many sources of strong evidence, an article in the Atlantic cites testimony from multiple internal sources that the decision was indeed politically motivated, rather than simply a concern about making sure that the Foundation was carrying out its fiduciary responsibilities:

According to the article's author: "three sources with direct knowledge of the Komen decision-making process told me that the rule was adopted in order to create an excuse to cut off Planned Parenthood. (Komen gives out grants to roughly 2,000 organizations, and the new "no investigations" rule applies to only one so far.) The decision to create a rule that would cut funding to Planned Parenthood, according to these sources, was driven by the organization's new senior vice president for public policy, Karen Handel, a former gubernatorial candidate from Georgia who is staunchly anti-abortion and who has said that since she is "pro-life, I do not support the mission of Planned Parenthood." (The Komen grants to Planned Parenthood did not pay for abortion or contraception services, only cancer detection, according to all parties involved.)"

"The decision, made in December, caused an uproar inside Komen. Three sources told me that the organization's top public-health official, Mollie Williams, resigned in protest immediately following the Komen board's decision to cut off Planned Parenthood. Williams, who served as the managing director of community-health programs, was responsible for directing the distribution of $93 million in annual grants. Williams declined to comment when I reached her yesterday on whether she had resigned her position in protest, and she declined to speak about any other aspects of the controversy. Three sources told me the organization's top public-health official, Mollie Williams, resigned in protest immediately following the Komen board's decision to cut off Planned Parenthood.

"But John Hammarley, who until recently served as Komen's senior communications adviser and who was charged with managing the public-relations aspects of Komen's Planned Parenthood grant, said that Williams believed she could not honorably serve in her position once Komen had caved to pressure from the anti-abortion right. "Mollie is one of the most highly respected and ethical people inside the organization, and she felt she couldn't continue under these conditions," Hammarley said. "The Komen board of directors are very politically savvy folks, and I think over time they thought if they gave in to the very aggressive propaganda machine of the anti-abortion groups, that the issue would go away. It seemed very shortsighted to me."

"Hammarley explained that the Planned Parenthood issue had vexed Komen for some time. "About a year ago, a small group of people got together inside the organization to talk about what the options were, what would be the ramifications of staying the course, or of telling our affiliates they can't fund Planned Parenthood, or something in between." He went on, "As we looked at the ramifications of ceasing all funding, we felt it would be worse from a practical standpoint, from a public-relations standpoint, and from a mission standpoint. The mission standpoint is, 'How could we abandon our commitment to the screening work done by Planned Parenthood?'" But the Komen board made the decision despite the recommendation of the organization's professional staff to keep funding Planned Parenthood." ...

"Another source directly involved with Komen's management activities told me that when the organization's leaders learned of the Stearns investigation, they saw an opportunity. "The cart came before the horse in this case," said the source, who spoke to me on condition of anonymity. "The rule was created to give the board of directors the excuse to stop the funding of Planned Parenthood. It was completely arbitrary. If they hadn't come up with this particular rule, they would have come up with something else in order to separate themselves from Planned Parenthood."

The insincerity of the Komen Foundation can easily be seen in the way it is administering this new policy. For example, it cut off funding for Planned Parenthood, but why did it not also cut announce that it was cutting off grants to Yale University, which is listed as a grantee in the Foundation's 2010-2011 financial statements? After all, according to the Yale Daily News, Yale University is under investigation for " an alleged mishandling of several instances of sexual misconduct in recent years," which - if true - represents a violation of federal law.

And why did the Komen Foundation not announce its discontinuation of grants to Columbia University, also listed as a grantee in the Foundation's 2010-2011 financial statements? After all, according to the Columbia Spectator: "The U.S. Department of Education’s Office for Civil Rights is investigating a complaint accusing Columbia of discriminating against a Jewish student."

Another grantee listed in the Foundation's 2010-2011 financial statements - the University of California at Santa Cruz, is also under a federal investigation, according to this article. Why is UCSC not the subject of a Komen Foundation announcement regarding termination of funding?

And of course, why is the Komen Foundation not announcing termination of funding to Penn State University, a grantee according to this 2011 financial statement? As we all know, Penn State is the subject of a federal investigation into potential violation of federal law in not properly reporting suspected cases of sexual abuse.

It is quite clear that the Komen Foundation is continuing to pull the wool over the eyes of its supporters, former supporters, constituents, and the public. By not coming clean about the true reasons for the change in grant policy and by furthering, rather than correcting, its deception of the public, the Foundation is in some ways making things worse, rather than better. It is continuing to make decisions based on politics and not a sincere interest in sharing the truth.

A true apology needs to be an honest one and the organization needs to take responsibility for its actions and be transparent about the reasons for poor decisions. By continuing to deceive the public - and in fact deepening the deception by directly denying the true reasons for its actions - the Komen Foundation is sinking deeper into a political hole rather than managing its way out of the hole it has created.

The revised grant policy makes no sense. It states: "disqualifying investigations must be criminal and conclusive in nature and not political." What the heck does "conclusive" mean? An investigation is neither conclusive nor non-conclusive. It is the results of the investigation that may be conclusive or not. Either the investigation concludes that wrongdoing occurred or it does not. How would one determine whether an investigation is "conclusive," and what does that even mean?

It certainly looks like the Foundation is trying to weasel its way out of a tight spot by having us believe that there is actually some logical meaning behind this clarification of the type of investigation that "counts." It's a nice try, but it's not convincing.

Even the criterion of whether an investigation is "political" or not is problematic. An anti-abortion rights Board member could easily (and would likely) argue that the Planned Parenthood investigation is not political, but based on concern about violation of federal policy. The way the new policy is written, it almost ensures that decisions will be made based on politics rather than science.

In fact, it is quite clear that this is an untenable and contrived policy that represents little more than a thinly-veiled attempt to dance around and try to get out of the mess it has created without being honest about the true story.

The Foundation further muddies the waters by stating: "We will continue to fund existing grants, including those of Planned Parenthood, and preserve their eligibility to apply for future grants, while maintaining the ability of our affiliates to make funding decisions that meet the needs of their communities." Just what is this last clause supposed to mean and why is it necessary? Why not simply state that the Foundation will continue to fund Planned Parenthood? Why is a qualification clause necessary to note that affiliates will have the ability to make funding decisions that "meet the needs of their communities" in context of the Planned Parenthood issue?

If the Foundation truly wishes to "move past this issue," then it first must come clean, be honest with the public, and stop this public deception. It must tell the truth about the intentional attempt to cut off funding for Planned Parenthood, admit that the decision was political, apologize sincerely. Then, and only then, can it move past this issue.

While this whole episode has actually helped Planned Parenthood in the long-run by increasing its funding (a number of supporters came to its aid in the 48 hours after the media coverage of the termination of funding from Komen) and by exposing the political motivations of Planned Parenthood's attackers, thus undermining those attacks, the Komen Foundation is facing potentially irretrievable damage because of the destruction of its brand.

The rest of the story is that while the Komen Foundation did the right thing by reversing its decision and restoring funding to Planned Parenthood, it did the wrong thing by continuing to deceive the public about the real reasons behind the funding policy change and by being dishonest about its true initial intention -- which was specifically to find a way to cut off funding for Planned Parenthood.

Everyone is entitled to forgiveness and apologies can always be accepted so that all parties can move forward, but this requires - first and foremost - a sincere and honest apology that admits the wrongdoing and does not try to hide it or the motivations behind it. Until the Komen Foundation shows us that it is willing and able to tell the truth, there cannot and will not be a restoration of the public's trust and its brand will remain tarnished. Sadly, the continued tarnishing of the Komen brand is unfair and destructive to women with breast cancer and to women in general.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.